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1 Introduction

When an acoustic pressure wave travels down the ear canal toward the TM, the frequency-

1

dependent power P(f ) [W],1 which is defined as the flow of energy over time and space,

2

is continuous until it reaches an impedance discontinuity, such as a change in the area of

3

the ear canal, or the tympanic membrane (TM). Such variations in the wave propagation

4

result in frequency dependent reflections. The ratio of the reflected to absorbed power is

5

called the power reflectance.The ratio of the reflected to absorbed pressure (or velocity) is

6

called the complex pressure reflectance. Historically reflectance is denoted by the upper

7

case Greek letter “gamma” Γ(f ).2

8

1.1 Absorbed and reflected waves

9

The key behind the reflectance measure is to decompose the acoustic wave into absorbed

10

and reflected components. The notation is simplified if we relabel the absorbed and

11

reflected waves in terms of their direction of travel. Thus we define pressures P+(f ) =

12

Pa(f ) and P(f ) = Pr(f ) where the “±” indicates the direction of travel of the wave.

13

This results in the pressure and velocity relations

14

P (f ) = P+(f ) + P(f ) (1)

15

and

16

U (f ) = U+(f ) − U(f ). (2)

17

The pressure (like voltage) is a scaler, while the velocity (like current), is a vector, with

18

direction. This explains the change in sign of Eq. 2.

19

At each point x along the canal, the ratios of the pressures P± and velocities U± are

20

equal to the acoustic resistance, which due to conservation of energy must always be

21

positive and real. Thus

22

ρc

A(x) = P+(f )

U+(f ) = P(f )

U(f ), (3)

23

where ρc = 407 [Rayls] and A(x) is the canal area at location x along the ear canal.

24

If we reorganize the above equation we obtain the definition of the complex reflectance

25

Γ(f ) = P(f )

P+(f ) = U(f )

U+(f ), (4)

26

in terms of the ratio of reflected over absorbed pressure (or velocity). This relationship

27

is complex, thus Γ may be written either as the sum of a real and imaginary part, or in

28

terms of its magnitude and phase3 (Eq. A.4).

29

1For clarity all SI units will be displayed in square brackets.

2This article assumes the reader knows mathematics at the level of high school algebra. In keeping with this assumption, we will use mathematical notation, which frequently includes Greek letters. Using mathematical notation is simpler because it precisely specifies the variables via a unique symbol.

3Given the nature of the topic it is necessary to use complex numbers to represent pressure and velocity, and their ratio, which defines the impedance at a given frequency. For example, the algebraic sentence Γ(f ) = |Γ(f )|e says that the complex reflectance Γ(f ), as a function of frequency f , is equal to the magnitude of Γ at each frequency, times the exponent of the phase φ, or angle. Here e= cos(φ) + j sin(φ) is called Eulers formula (j =

−1).

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The beauty of complex reflectance over the complex impedance is that the magnitude

30

reflectance |Γ(f )| describes the relative absorbed power as a function of frequency, while

31

the phase codifies the latency of the absorbed power (e.g., depth of the reflected wave).

32

Furthermore complex reflectance has certain properties that render it more useful than

33

impedance in forming a diagnosis of a ME pathology.

34

Thus the complex reflectance has an intuitive interpretation, whereas most people

35

find complex impedance difficult to master. Within the clinical audiology community it

36

is well know that impedance is a difficult concept. Part of the problem is the obtuse

37

terminology, as outline in Table B1. But terminology is not the entire story. Even

38

those who say they understand complex impedance find it difficult to explain to lay

39

persons. One obvious reason for this is that the transformation from complex reflectance

40

to complex impedance is complicated [Voss and Allen, 1994]. Other than for the simplest

41

of cases, this transformation is mathematically challenging.4

42

It should be noted however that, regardless of the complexity of the relationship,

43

complex impedance and reflectance are mathematically equivalent. Since reflectance is

44

easily understood, and impedance is not, we shall focus on the complex reflectance in

45

this report.

46

Estimating Γ(f ) requires a special calibration of the earphone, known in the Engineer-

47

ing literature as a Th´evenen calibration. While quite important, this measure is beyond

48

the scope of the present discussion.5

49

Voss and Allen [1994] were the first to use the complex reflectance to characterize the

50

acoustic properties of the TM, by approximately removing the effect of the residual ear

51

canal. When the area of the canal is constant the TM reflectance Γtm(f ) is related to

52

the measured microphone reflectance Γm(f ) by the relation

53

Γm(f ) = Γtme−j2πf 2L/c (5)

54

where L is the distance from microphone to TM and c is the speed of sound. Simply

55

stated, this equation says that there is a round trip delay of 2L/c between the measure-

56

ment point and the TM. Thus if one can estimate L they then can compute Γtm(f ), which

57

is mathematically equivalent to the TM impedance. But there is one further complica-

58

tion. When the area of the canal depends on position, the effective length L depends on

59

frequency. This complicates this relationship, for both practice and theory.

60

Thus if one could estimate L, then one may estimate Γtm(f ) from the measured

61

Γm(f ). An accurate procedure for doing this that includes the case of variable canal area

62

was reported by Robinson and Allen [2013]. For most clinical applications Γtm(f ) is the

63

starting point for the analysis of ME pathologies.

64

The remainder of this chapter is focused on clinical applications of complex reflectance

65

and the effect of ME pathologies.

66

1.2 Clinical applications of the complex reflectance

67

Next we discuss some of the main applications of the complex reflectance method. The

68

first is the Forward pressure level which is a method for calibrating the signal in the

69

ear canal so that the pressure delivered to the cochlea is approximately constant, thus

70

4This transformation is known as a M¨obius, or bilinear, transformation.

5http://en.wikipedia.org/wiki/Thevenin’s_theorem

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100 101

−25

−20

−15

−10

−5 0

FPL correction factor: |1+Γ|/2

20 log 10(|1+Γ|/2) [dB]

f [kHz]

Figure 1: Forward pressure level normalization factor which corrections the ear canal standing wave. At the null frequency f0, the phase of the complex reflectance (i.e., the angle of Γ(f0)) is 180 degrees [Withnell, 2010, 2009b]. This explains the source of the standing wave nulls, and their unpredictable nature, since the frequency critically depend on the round trip delay from the source back to the microphone (Eq. 5). This delay is different for each ear, as it dependent on the insertion depth of the probe and the geometry of the canal and TM.

removing troubling ear canal standing waves. A second application is a method to remove

71

the effect of the residual ear canal, defined as the section of canal between the microphone

72

and the TM. Clinically what we really need to know is the reflectance at the TM. This

73

is distorted by the round trip delay of the residual ear canal. Finally, given the complex

74

reflectance at the TM, it is possible, in theory at least, to diagnose most, if not all, middle

75

ear pathologies.

76

What the research clinician would most like to know is the transmission properties

77

of the ME. Specifically is the ME clinically normal? If not, in what way is it abnormal?

78

There is a host of possible abnormalities. The most common are: 1) TM abnormalities,

79

2) Ossicular disruption and ossification, 3) Fluid in the middle ear, 4) Eustachian tube

80

dysfunction. There is building evidence that the TM complex reflectance can be used

81

to both identify, and then quantify (diagnose) most, if not all of these pathologies. We

82

shall present the evidence in support of this hypothesis.

83

Forward pressure level and its applications: Real ear measurement systems use a

84

microphone in the ear canal to account for variation in the subject’s ME. This methods is

85

intended to replace traditional but less reliable coupler calibrations, which do not account

86

for these natural variations. In principle this seems like a logical thing to do. However

87

there are several serious problems that need to be addressed. The most obvious of these

88

is the effect of standing waves in the canal [Siegel, 1994]. While the canal standing wave

89

problem has been recognized for a long time, there have been years of debate as to how

90

to best deal with it. There was considerable uncertainty in the beginning, as to the best

91

quantity to normalize, with the intensity being one obvious candidate (Gorga and Neely,

92

1998; Souza, 2014; Keefe et al.).

93

The nature of these standing waves is shown in Fig. 1. Based on the deep nulls

94

seen in the figure, clearly would not be reasonable to normalize the microphone pressure

95

Pm(f ) to be a constant. Such a normalization would boost the level at the standing

96

wave null by as much as 25 [dB]. The frequency of this boost would depend on the

97

microphone placement. However this is precisely what is done in real ear measurements

98

when the microphone level is re-normalized to be constant. Real-ear calibrations have

99

the unintended effect of putting a large peak at the standing wave frequency.

100

But it now appears that this question has been satisfactorily resolved by the research

101

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community. It is now recognized that the forward pressure level (FPL) should be made

102

constant [Souza, Dhar, Neely, Siegel 2014 (9 methods; JASA)]. However, other than some

103

research systems, FPL has not made it into clinical equipment at the time of this writing.

104

This calibration procedure is a variant on the so-called RETSPL method, where the

105

voltage on the transducer is varied to maintain the pressure at the TM constant in an ar-

106

tificial ear. Here we coin the term RETFPL (reference equivalent forward pressure level).

107

The procedure is: Given the microphone pressure Pm(f ) and its corresponding complex

108

reflectance Γm(f ), compute the forward pressure P+(f ). Vary the receiver voltage so

109

that P+(f ) is constant at the desired level.

110

One may determine P+(f ) as follows:

Pm(f ) = P+(f ) + P(f )

= P+(f )



1 + P

P+



= P+(f )(1 + Γm(f )).

Solving for P+ gives

111

P+(f ) = Pm(f )

1 + Γm(f ). (6)

112

Since the microphone pressure and the complex reflectance are both known, one may

113

easily solve for the absorbed (i.e., forward) pressure by the above relation. While some

114

alternative methods have been tried, it seems unlikely that, without knowledge of the

115

complex reflectance Γ(f ), the precision needed to estimate the standing wave frequency

116

will be inadequate.

117

Fig. 6 shows the normalization factor for 10 human ears, taken from [Voss and Allen,

118

1994]. As the frequency is increased above 3 [kHz], the phase plays a very important

119

role, as it can result in ear canal standing waves, as seen by the canal microphone. This

120

phase relation is negligible at low frequencies, where it is small. At higher frequencies,

121

the phase, due to the round trip delay from Tagus to TM (2.5 cm) of ≈150 [µs], gives a

122

standing wave null at ≈3.4 [kHz]. If one includes the additional delay in the TM (≈45

123

µs) and ossicles, the frequency null can be even lower. Examples of these nulls, as shown

124

in Fig. 1, have been computed from the complex reflectance using the relation

125

FPL = 20 log10

1 + Γ(f ) 2

.

126

The extra factor of 2 is to compensate for the fact that Γ(f ) goes to 1 as the frequency

127

goes to zero. Thus the sum of the two terms is 2, which is removed by this factor. The

128

use of this extra factor is optional depending on the interpretation of what is desired at

129

low frequencies. This factor is know in the literature as the missing 6 dB.

verify this claim.

130

To experimentally verify this formula consider the following experiment. If we mea-

131

sure the pressure at the end of a rigid cavity, and normalize P+(f ) to be a constant

132

(say 1 [Pa]), then at the end of the cavity, Γ(f ) = 1 (since the cavity is rigid). Thus

133

P(f ) = P+(f ) = 1. It follows that the pressure at the end of the cavity is 2 since

134

P = P++ P= 1 + 1 = 2 [Pa].

135

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In summary: When a earphone excites sound in the ear canal, a forward traveling

136

wave is launched into the canal. This wave proceeds down the canal at the speed of

137

sound. Once it reaches the TM (or any other change in impedance) it is reflected by an

138

amount given by the TM reflection coefficient Γtm(f ), in a frequency-dependent manner.

139

This results in a backward propagating wave P(f ) = Γtm(f )P+(f ). All of the acoustic

140

physics of the TM is captured by Γm(f ). When the microphone measurement location

141

is not at the TM, there is a phase factor given by the round-trip delay between the TM

142

and the microphone location which is the source of the standing wave.

143

TM Acoustic admittance: From the clinical diagnostic point of view, the most im-

144

portant quantity is the acoustic admittance of the TM Ytm(f ). This is what tympanome-

145

try does not, and cannot accurately estimate. While the low frequency canal admittance

146

magnitude may be measured (this is what 226 [Hz] tympanometry provides), Ytm(f ) is

147

not measured at relevant (i.e., speech) frequencies. Furthermore, the complex TM admit-

148

tance is not accurately estimated from the canal admittance, even at 226 [Hz], because

149

the clinical procedure does not accurately remove the effect of the residual ear canal

150

[Shanks et al, 1981; Rabowitz, 1981; Shanks et al., 1988].

151

There are several challenges here. Clinically speaking, we would like to estimate the

152

wideband complex admittance at the TM given pressure measurements at some unknown

153

location in the canal. Note we do not know either 1) the length of the ear canal, nor 2)

154

the pressure at the TM. One might wonder if this is even a realistic goal.

155

What research clinicians would most like to know is the wideband complex reflectance

156

at the TM, Γtm(f ) = P(f )/P+(f ). As previously stated, given Γtm(f ) the complex

157

TM admittance or impedance are easily determined. The proposal then is to Thevenin

158

calibrate the ear canal probe. Then given the ear canal pressure Pm(f ) one may compute

159

the complex reflectance Γm(f ). Using the procedure of Robinson and Allen (2013), the

160

phase factor corresponding to the residual ear canal may be uniquely determined and

161

removed, leaving the desired Γtm(f ). This then puts us at the starting point for the ME

162

diagnosis, as reviewed next.

163

1.3 Overview of Middle Ear Impedance and Reflectance

164

The middle ear is remarkable for its functionality in converting air-born sound into fluid-

165

born sound, via the mechanical action of the TM and ossicles. Air-borne sound that

166

reaches the TM is converted to acoustic vibration of the TM. This vibration drives the

167

ossicles that transmit the acoustic signal to the annular ligament in the oval window

168

which, in turn, convey the signal to the fluid filled cochlea.

Perhaps mention the faults analogy of a flowing river, with a dam and tributaries.

169

A middle ear model The middle ear may be represented as a simple circuit, as shown

170

in Fig. 2. At low frequencies (i.e, 200 [Hz]), the delay may be ignored, and this model

171

reduces to a parallel combination of the compliance of the ear canal, the compliance

172

of the ossicular joints and the compliance of the annular ligament. Around 0.7-1 [kHz]

173

the impedance of the cochlea, which is well approximated by a constant resistance, is

174

approximately equal to the impedance of the annular ligament, bringing the cochlear

175

load into the picture. At higher frequencies, the delays of the several transmission lines

176

may not be ignored and the full model must be considered.

177

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Ear Canal Outer Ear

Ear Drum

Annular Ligament

≈37 µs delay

Mmalleus Mincus Mstapes

Pcochlea

Zcochlea

Figure 2: This shows a transmission line model of the middle ear including the outer ear (pinna and concha), the ear canal, represented as a tube, the tympanic membrane (ear drum), which is also a transmission line with approximately 37 ]µs] of delay. Following this are the ossicles consisting of the mass of the malleus, incus and stapes, shown here as electrical inductors.

Between each of these mass’s is the ligament which is represented as a spring, or in the electrical analog, a capacitor. The annular ligament holds the stapes footplate in the oval window. This spring is nonlinear since it changes its compliance when force is applied via the stapedius muscle.

Finally the cochlear impedance is represented as a resistance. This is also nonlinear in that it generates acoustic otoacoustic emissions, which are minuscule nonlinear retrograde signals (i.e., OAEs), close to the threshold of hearing for the normal ear. In this figure quote delay across and along canal. Add speaker source, for clarity, and to help raise the concept of the Thevenin source pressure and impedance, due to loading of the speaker by the ear canal. The speaker source impedance/admittance must be close to real given its very small size and internal structure [Kim].

The rapid growth in the use of otoacoustic emissions (OAEs) for hearing screening and

178

related diagnostic evaluations, has focused attention on the need for improved methods

179

of ME assessment [2]. The status of the ME is of key importance for the measurement of

180

otoacoustic emissions, since the external signal must first travel into the cochlea, followed

181

by the evoked retrograde otoacoustic emissions. Both are subject to attenuation from an

182

abnormal ME.

183

In the normal ME sounds are thus transmitted efficiently from the canal to the cochlea.

184

Relatively little acoustic power is lost in the normal middle ear (<3 [dB]) (Allen, 1986).

185

Research has shown that the middle ear is a cascade of transmission lines that are approx-

186

imately matched [Zwislocki, 1947; Moller 1965; Allen, 1986; Puria and Allen, 1991,1998].

187

This is expected, since loss would translate to poorer hearing. When this cascade of trans-

188

mission becomes unbalanced, reflections occur, and transmission is impaired. For this

189

reason the middle ear transfer of energy is very sensitive to any unbalanced impedance

190

elements within the ME structure.

191

The auditory system is extremely sensitive. The threshold of hearing at 1 [kHz] is ≈0

192

sound pressure level [dB-SPL]. This intensity corresponds to an average motion of the

193

stapes of ≈8 [pm] (i.e., ≈1/3 the radius of the Hydrogen atom (25 [pm]).

194

Due to the reciprocal nature of the middle ear, little power is lost for retrograde

195

signals; i.e., signals traveling in the reverse direction, from the oval window to the TM,

196

have similar loss characteristic as the forward traveling waves (Allen and Fahey, 1992). It

197

follows that minute vibrations generated in the cochlea by nonlinear motions of the outer

198

hair cells, can be measured in the ear canal. The measurement of these signals, known

199

as otoacoustic emissions (OAEs), are an important tool for studying the mechanism of

200

hearing.6 This has led to the development of powerful new techniques for the objective

201

assessment of hearing, such as cost-effective methods of world-wide hearing screening

202

6These signals were discovered by David Kemp and Duck on Kim, as first reported in the early 1970s.

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programs.

203

The ME is also remarkably robust. Sounds of extremely high intensity (on the order

204

of 120 dB SPL) do not damage it. The inner ear, in contrast, is subject to substantial

205

damage from sounds of this intensity (the cilia of the outer hair cells are most easily

206

damaged, which results in sensorineural hearing loss). The ME provides an effective

207

protective mechanism in the form of two middle ear efferent systems. The best understood

208

is the acoustic reflex via the stapedus muscle, which helps protect the cochlea from intense

209

low-frequency vibrations. This mechanism protects the inner ear from intense air-born

210

sound, but only to a limited extent; the acoustic reflex is too slow to protect the inner ear

211

from intense sounds of short duration [Add references on combat blast levels observed,

212

which can destroy the TM, i.e., 160 dB]. A second efferent system is the tensor tympani,

213

that connects to the long process of the malleus. This system may be used during

214

speaking and chewing.

215

1.4 Impedance Discontinuities cause Reflected Acoustic Power

216

The mechanical load on the TM is from the ossicles; thus, when one says the impedance

217

of the middle ear, what one really means is the ear-canal impedance at the microphone

218

location, which is a delayed version of the drum impedance that includes the impedance

219

load of the ossicles and cochlea (Fig. 2). Power reflectance varies as a function of fre-

220

quency and depends on how the acoustic impedance of the TM varies with frequency.

221

At frequencies below 1 [kHz], the impedance of the TM is due mostly to the stiffness of

222

the annular ligament [Lynch, 1981; Allen, 1986; 13]. When pressure waves at these low

223

frequencies reach the stapes, almost all of their power is briefly stored as potential energy

224

in the stretched ligament and then reflected back to the ear canal as a retrograde pres-

225

sure wave. At even lower frequencies (<0.8 [kHz]), only a small fraction of the incident

226

power is absorbed into the ME [14]. The impedance of the TM in this frequency region

227

essentially consists of a stiffness-based reactance.

228

In a normal ear, in the mid-frequency region between 1 and 5 [kHz], the stiffness- and

229

mass-based reactances of the ME interact in a complex way and largely cancel each other.

230

The ME is a complex structure (see Fig. 2) that consists of several stiffness components

231

and several mass components that all work in harmony such that the cancellation of reac-

232

tance occurs over a wide frequency range (1 to 5 [kHz]). As a result, most of the incident

233

power that reaches the TM in this region is absorbed into the ME and transmitted to

234

the inner ear. In the low- and high-frequency regions the TM resistance is typically small

235

compared with its reactance, whereas in the mid-frequency region the resistance is larger

236

than the combination of the stiffness- and mass-based reactances.

237

The stiffness based reactance is inversely proportional to frequency (i.e., it is halved

238

with each doubling of frequency), while the resistance is constant across frequency. For

239

frequencies at the lower end of the auditory range (e.g., 0.1 [kHz]), the reactance is more

240

than 10 times the resistance, but in the region of 1 [kHz], the reactance and resistance

241

are of comparable magnitude. At frequencies above 6 [kHz], the mass-based reactance

242

of the ossicles becomes increasingly important and, because it is linearly proportional to

243

frequency, it can eventually dominate the TM impedance. This is complicated by the

244

fact that the center of mass of each ossicle barely moves. Thus the relevant mass is not

245

the ossicle mass, rather it is the rotational inertia of each ossicle.

246

To further complicate matters, our experimental knowledge of TM impedance is rel-

247

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atively poor at frequencies above 6 [kHz]; thus, the frequency at which mass-based reac-

248

tance becomes the dominant component of TM impedance typically is unknown. When

249

a high-frequency pressure wave reaches the TM and mass-based reactance is substan-

250

tial, most of the power in the incident pressure wave is momentarily stored as kinetic

251

energy, primarily in the ossicles, and then reflected back to the ear canal as a retrograde

252

pressure wave. At high frequencies, much of the published data shows an impedance

253

that approaches that of a mass as the frequency is increased. Mass-based reactance is

254

linearly proportional to frequency (i.e., it doubles with each doubling of frequency), while

255

cochlear resistance varies only slightly with frequency [15]. Between 1 and 5 [kHz] the

256

resistance and reactance are of comparable magnitude, whereas at very high frequencies

257

the mass reactance can be several times greater than the cochlear resistance.

258

2 Methods

259

2.1 General properties of reflectance and admittance

260

Definitions of acoustic variables: The acoustic intensity of sound in the ear canal is

261

I(t) = p(t)u(t) [W/m2], where p(t) is the pressure in Pascals [Pa]as functions of time t.

262

The acoustic power P is the Acoustic intensity I times the cross-sectional area A [m2] of

263

the ear canal, namely P(t) = A(x) I(t) [W]. In general the area varies along the length

264

of the canal x [m]. The acoustic particle velocity [m/s] times the canal area A(x) is called

265

the volume velocity [m3/s].

266

The intensity and power may be defined either in the time or frequency domains. It

267

is important to be aware of which domain (time or frequency) is being discussed, as these

268

are very different ways of looking at I and P. Ideally we should have different notation

269

for intensity and power in the time and frequency domains. Here we shall work almost

270

exclusively in the frequency domain, where all variables shall be define in terms of a pure

271

tone of magnitude and phase [radians].

272

The ratio of the pressure over the volume velocity is the acoustic impedance, which for

273

a simple plane wave in the ear canal is ρc = 407/A(x) [Acoustic Ohms], where c = 343

274

[m/s] is the speed of sound and ρ = 1.2 [kgm/m3] is the density of air. For reference,

275

1 Pascal [Pa] is 94 [dB-SPL], which is typical of yelling. Typical speech is close to 65

276

[dB-SPL] 1 [m] from the mouth. The average threshold of hearing defines 0 [dB-SPL]

277

which is 20 [µPa], i.e., 20×10−6[Pa]. If voltage is something you feel you understand, the

278

think of the pressure as “acoustic volts.” Details of these relations are further discussed

279

in Appendix A.

280

When the ear canal area is constant, the propagation delay is constant and the phase

281

is proportional to frequency. For example, given a delay T the phase is φ = −T ω, where

282

ω = 2πf is called the radian frequency.

283

When the area depends on position (e.g., A(x)), the phase (and thus the delay)

284

depends on frequency. Fortunately this dependence, between φ(f ) and A(x), is typically

285

small. Since the phase slope defines a delay, which is related to distance by the speed of

286

sound, the phase can provide information about the location of the reflections.7 Namely

287

the frequency dependent latency can be used to determine where the reflections occur in

288

the ME. A short latency means in the middle ear or TM, while a large latency means

289

7i.e., data from Sarah R.

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deep in the cochlea. Examples of this relation will be provided in later sections.

290

Furthermore the phase can tell us even more about the latency of the power absorbed.

291

Since the theory behind the complex reflectance is quite mathematical, it is not presented

292

here. However given the complex reflectance (or equivalently the complex admittance

293

or impedance), the reflections, as a function of depth, is estimated by a well defined

294

procedure.

295

Ear-canal reflectance and impedance were robustly measured with the use of the

296

multi-cavity technique first developed by Moller [1961], due to Allen [9,10,14], that makes

297

the cavity calibration method more robust to measurement problems. An ear-canal probe

298

that consists of an earphone (called a receiver in the telephone literature) and microphone

299

(aka, a transmitter) is inserted into the ear canal.

300

2.2 False positives and the middle ear

301

JLM: Remove - out of dateJBA: In what way is it out of date? Can you be more specific?

302

Lets find some clinical person that can discuss this with us, like Linda Hood? I think

303

that what they do is keep testing till they get a pass. They do try to bring the child back

304

at a later time. That does not change the statistics however. its still very expensive.

305

A major factor that contributes to the high cost of large-scale (e.g., universal) hearing

306

screening programs is the high rate of false positives. This rate is high because of the

307

inability of current screening methods to distinguish between minor conductive disorders

308

(such as a temporary blockage in the ear canal or ME) and serious inner-ear pathologies

309

(such as a sensorineural hearing loss). The practical consequences of this problem are

310

severe, since the incidence of conductive disorders is roughly 30 times greater than that

311

of inner-ear pathologies in infants [3-5].

312

Consider, for example, a universal screening program for infants: for every 1,000

313

infants screened, we expect 2 or 3 to have an inner-ear pathology (0.2%-0.3%) and 50 to

314

100 to have a conductive disorder (5%-10%). Virtually every infant with a conductive

315

disorder will be positive (fail) the screening test and subsequently require a more extensive

316

evaluation, which is expensive in both time and effort. In addition to high false-positive

317

rates, most hearing screening programs have a narrow scope. The primary objective

318

of these screening programs is to identify children with inner-ear pathologies that can

319

cause negative long-term consequences. Very few screening programs attempt to identify

320

ME pathologies in infants and newborns because of the poor reliability of instruments

321

designed for this purpose and the testing difficulty. A significant weakness of these

322

screening programs exists since chronic conductive disorders, such as otitis media with

323

effusion, also can have serious and long-term negative consequences, thus need to be

324

identified early.

325

In order for a hearing screening program to be cost-effective, the false-positive rate

326

must be substantially reduced (e.g., reduction by a factor of >30 is required to make

327

false-positive rates negligibly low and referral rates acceptable). The only possible way

328

to achieve this reduction would be with a test that can distinguish between conductive

329

disorders and inner-ear pathologies. This suggests a measure of acoustic power reflectance

330

simultaneously with otoacoustic emissions, so that we can evaluate the status of the

331

ME. Fortunately, instrumentation developed for otoacoustic emission hearing screening

332

can be modified to measure acoustic power reflectance. An instrument that combines

333

these measurements has the potential to simultaneously screen for both ME and inner-

334

(10)

ear pathologies. This would not only reduce the false-positive rate and improve cost-

335

effectiveness, it would also allow for the identification of a range of different pathologies,

336

both middle ear and cochlea.

337 JBA edits to

here

2.3 Measurement Technique

338

The earphone generates the test sound and the microphone then records either a cavity

339

or ear canal pressure. The acoustic properties of the probe system are then determined

340

with the use of frequency responses in the four rigid cavities of known impedance. The

341

ear-canal pressure and the four cavity pressures are then processed to produce an estimate Briefly

mention why 4 cavities are used.

342

of the ear-canal power and pressure reflectance.

343

Etymotic Research, Elk Grove Village, Illinois, developed the ER-10C, a distor-

344

tion product otoacoustic emission (DPOAE) ear-canal probe used in this investigation.

345

The frequency-response measurements were obtained with the use of Mimosa Acous-

346

tic’s HearID (Champaign, Illinois), an automated acoustic measurement system used for

347

DPOAE measurements. Similar methods of measuring reflectance and impedance have

348

been developed in recent years. Most of these techniques use a multi-cavity approach

349

that differ primarily in terms of the size, length and the number of calibration cavities

350

[11,16].

351

Reflectance can also be derived from measurements of acoustic impedance with other

352

methods such as the two microphone method, or the standing-wave tube method [15].

353

These various methods for measuring the acoustic impedance of the ear have been de-

354

veloped over the years [17]. Many of these early methods, which do work, have been

355

shown to be relatively inaccurate. In contrast, the four-cavity method used in this study

356

is suitable for clinical use and has been shown to be accurate from 0.1 to >8.0 [kHz], as

357

determined by measurements of standard couplers with known impedance [9] and a pair

358

of standard acoustic resistors of known resistance [10]. This improvement in accuracy is

359

mainly due to fewer assumptions. For example, the two microphone method requires a

360

precise calibration of the microphones, including their relative placement, and the stand-

361

ing wave tube method requires manual manipulation of the microphone placement. The

362

main disadvantage of the four cavity method is the need to verify the calibration each

363

day prior to any measurements, to assure that the ER-10C probe has not changed in

364

its acoustic properties. As probe technology improves, hopefully this disadvantage will

365

eventually be removed.

366

Clinical tympanometric methods have earlier been developed for measuring the re-

367

ciprocal of impedance (i.e., admittance) at a few frequencies, but the frequency range

368

of these instruments is limited to around 1 [kHz]. Recently reflectance-tympanometry

369

has been developed, mainly by Interacoustics. The utility of this composite measure is

370

presently under investigation. One of the issues with this approach is how to automati-

371

cally extract clinically useful results, and this has been the subject of on-going research

372

(Sun, Ear and Hearing articles, 2012-14). Typically tympanometry does not work in in- Better

references required 373

fant ears due to the very compliant nature of their ear canal (Margolis et al. [18]; Keefe

374

and Simmons [19]; Hunter book).

375

The reflectance measurement protocol in this study, which includes measurements of

376

acoustic impedance and related acoustic properties of the ear, uses technology that was

377

initially developed for otoacoustic emission hearing screening [20]. The measurements

378

have a bandwidth of 0.1 to 6.0 kHz, which is substantially greater than the bandwidths

379

(11)

100 101

−10

−8

−6

−4

−2 0

Absorbance: 10log 10(1−|Γ|2 ) [dB]

f [kHz]

Absorbance Test/Retest: o:S1, +:S2, x:S7, s:S9

Figure 3: Absorbance from three ears published by Voss and Allen (1994). blah blah

of most clinical instruments currently in use for assessing ME function (e.g., instruments

380

for measuring acoustic immittance). Unlike tympanometry, the system described here

381

does not vary the static pressure that is applied to the TM. While such a measurement is

382

useful for determining the static pressure behind the TM, it greatly complicates acoustic

383

power assessment.

384

Verification: This is a procedure that may be used as a check to be sure that the

385

system is working correctly. In its simplest form, one measures the reflectance of a

386

syringe or hard-walled loss-less cavity. In this case |Γ(f )| ≈ 1, which verifies the loss-less

387

condition. This is a very rigorous test, perhaps too rigorous. A deviation from 1 by a

388

few [dB] (1 dB is ≈12%) in pressure, which is not considered significant. Larger errors

389

are expected above 5 [kHz] due to small phase shifts at higher frequencies. Since an ear

390

is not a rigid cavity, perhaps a more easily interpreted test is to measure in an artificial

391

ear. However such a coupler may not be as handy as a syringe.

392

The ear-tip can also create errors. If the ear-tip is pushed against the ear canal,

393

creating a small constriction, the phase error may be introduced. Such a block can only

394

be established by replacing the ear-tip back in the canal. At times the ear-tip can become

395

clogged with crumen. In such cases, the solution is to replace the tip with a clean one.

396

Examples of the absorbance shown on a [dB] axis are given in Fig. 3.

397

2.4 Normative data sets

398

Four sets of data are described for illustration and were collected in different laboratories

399

with different power flow measurement equipment. These data are unpublished except Methods for

Normative data sets. All this needs updates.

Judi please help.

400

for the infant otitis media with effusion (OME) data. The first three data sets for the

401

adult cases (normal, otosclerosis, and perforated ear drum) were collected with the use

402

of the Reflectance Measurement System IV (Mimosa Acoustics, Inc.), which consists of a

403

digital signal processing (DSP) board, a preamplifier, an ER-10C probe, and a calibration

404

cavity set (CC4-V).

405

The OME data were collected with the Multiple Frequency Impedance and Re-

406

flectance Power Flow Analyzer system that consists of a laptop computer with a DSP

407

board, an ER-10C probe, and a similar cavity set (CC4-II). The power flow and re-

408

flectance measurements are based upon the four-cavity TM acoustic impedance measure-

409

ment methods developed by Allen [9]. The data for the three adult ears were collected

410

References

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